2D Vaccine Barcode Pilot

2D Vaccine Barcode Pilot 2012 AIRA Annual Conference September 19, 2012 Ke n Ge rlach, MPH, CTR Immunization Services Division National Center for Immunization & Respiratory Diseases 1 Immunization Services Division National Center for Immunization & Respiratory Diseases

Outline What are 2D Barcodes? Why are 2D Barcodes Relevant to Registries? 2D Vaccine Barcode Pilot Overview & Update 2

Two-Dimensional (2D) Barcodes General Information Read using image-based scanning Expand relative to data quantity encoded Store data horizontally and vertically Some error correction capabilities Dozens of 2D barcode symbologies exist Significance to Vaccines Larger data capacity than linear barcodes More information in a smaller space (on vials/syringes) 3

2D Barcode Symbology Examples Typ e Exam p le Data Characteristics Use Case Reader Lin e ar Barcod e Databar Limited Maximum 56 a/n chars Consumer products Linear Scanner Lin e ar Barcod e GS1-128 Maximum 48 a/n characters Logistics units (SSCC) Pharmaceutical Linear scanner Quick Response (QR) Barcod e Maximum 4296 a/n characters Consumer products Image scanner 2D Datamatrix Barcod e GS1 Datamatrix Max 2335 a/n characters Healthcare items Direct part Image scanner You will find this on pilot vaccines RFID Typically contains 2048 characters Logistics RFID reader Gen 2 Passive 4 Source: GS1-2011

GS1 DataMatrix for Vaccines AAP / GS1 collaboration Currently contains GTIN, Expiry Date and Lot Number GS1 DataMatrix symbology currently on multiple vaccines http://www2.aap.org/immunization/pediatricians/pdf/barcoding_guidance_manufacturers_022212.pdf 5

GS1 Global Trade Item Number (GTIN) Globally unique GS1 Identification Number used to identify trade items Assigned by the brand owner or manufacturer of the product 14 digits: 1st digit Indicator digit for packaging (can be 0 filled) Next 2 digits 03, GS1 US Placeholder Next 10 digits National Drug Code (in the US) Last 1 digit Check Digit Example: 0 0 3 0 1 2 3 4 5 6 7 8 9 6 National Drug Code 6

Scanned 2D Barcoded Vaccine Data Example 01003492815890581713102810U4275AA GTIN = 0034928158905 Expiration Date = 131028 Lot # = U4275AA GS1 Application Identifiers (AI) 01 GTIN 17 Exp iry 10 Lot/Batch Number 01003492815890581713102810U4275AA 7

Relevance to Registries Needed for 2D Barcode Scanning Enablement Ability to Translate GTIN to NDC to CVX/MVX Procedures to maintain GTIN to NDC mapping Listening mode for scanning Recognized Need - Future Implementation IIS/EMR functional requirements documentation Provision of technical support to non-pilot sites (providers & registries) 8

2D Barcode Vaccine Pilot Objective: To assess the extent to which using 2D barcoded vaccines and scanners affect the completeness and accuracy of vaccine data collected by pilot sites. Part 1 Pilot Project to Implement 2D Barcodes on Vaccine Vials and Syringes Work Flow Analysis Part 2 Incorporate 2D Barcodes onto Vaccine Information Statements (VIS) Part 3 Provide Technical Support and Guidance for Future Implementers 9

Project Timeline with Major Milestones Ye a r - 2011 2012 2013 Month - Sep Oct Nov Dec Jan Feb Mar Ap r May Jun July Aug Sep Oct Nov Dec Jan Feb Mar Ap r May Jun July Aug Sep Duration - 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Monthly Status Updates - Pilot Protocol Immunizer HW Immunizer Provisioned Enrollment Pilot Planning Pilot Execution Post Pilot Assessment Manufacturer Enrollment VIS Education and Training Materials EMR, IIS, Inventory SW Immunization Tracking begins Immunizer SW Needs Report Final Pilot Report VIS Encoding Manufacturer Forum Manufacturer Meeting Educational Forum Manufacturer Forum Report Education Education Forum Forum Re p ort Deliver Portal DataMatrix Manual Program Support We are here 10

Pilot Implementation Information Flow Manufacturer Immunizer Record system IIS Add a 2D barcode to the primary packaging: Data Matrix barcode to contain o GTIN* o Expiration date o Lot number Distribute to pilot participants Record and track data: Scan barcode when inventorying and dispensing vaccine products and enter into the medical record Medical record types: Electronic medical records (EMR) Custom applications Acts as a source of evaluation for data accuracy and completeness Receive data from the immunizers EMR or equivalent electronic system: Acts as a source of evaluation for data accuracy and completeness 11 *The Global Trade Item Number (GTIN) is a unique identifier used globally to identify an item. For vaccines and other health care products, the GTIN is specifically used to carry the National Drug Code (NDC) a unique identifier used in the US as mandated by the FDA.

Pilot Participants Manufacturers and original August 1 st vaccines Sanofi Menactra, Pediatric DT GSK HAVRIX Ad u lt New 2D Vaccines Sanofi - Ad ace l, Fluzon e, Dap tace l, Te n ivac, IPOL, Pen tace l Providers - Immunizers 222 immunizers enrolled 13 selected for work flow analysis (WFA) CDC Immunization Program Grantees 10 enrolled 12

Participating Immunization Grantees WA Chicago Philadelphia NYC MT ND ME OR ID WY SD MN WI MI NY V T N H MA C RI T CA NV UT CO NE KS IA MO IL IN KY OH WV PA MD VA NJ DE AZ NM OK AR TN SC NC Washington, DC MS AL GA TX LA HI AK Houston FL San Antonio Dallas Participating Immunization Grantee US Mountain/West US Midwest/Central US East 13

26 29 42 13 Immunizer Demographics Immunizer Participants 26 13 41 14 9 9 Oregon New York City New Jersey Wyoming Alaska New York Florida Washington Iowa Michigan Immunizer Data Entry Models 40 18 46 118 Double Data Entry EMR-Connected to IIS EMR-Manual upload to IIS IIS Only 14

Immunizer Demographics 148 Immunizer Segments 73 1 Public Private Commercial 90 51 Practice Specialties 67 Family Practice General Practice Internal Medicine Pediatric Other 10 Public Private Commercial 4 Family Practice 13 54 0 General Practice 8 2 0 Internal Medicine 0 4 0 Pediatric 4 84 0 Other 48 2 1 Over 70% of Other are Public Health Departments The single commercial practice is a commercial pharmacy that administers vaccinations. 15

EMR Types in the Pilot EMR Vendor Total AllScripts 45 Amazing Charts 1 Cerner 2 e-addabbo 5 eclinical Works 27 e-md 5 Encounter Pro 1 EPIC 19 EMR Vendor Total GE Centricity 5 Insight Netsmart 13 Medent 24 Mitchell & McCormick 3 NetPractice 1 NextGen 12 Office Practicum 16 Practice Partner 2 EMR Vendor Total Praxis 2 Profiler (Unicare) 4 QS1 1 RPMS 7 Sage Intergy 5 SIS 3 SuccessEHS 2 No EMR 17 Fully integrated 2D scanning capabilities Partially integrated 2D scanning capabilities No integrated 2D scanning capabilities 16

Evaluation Components 1. Accuracy and Completeness 2. User Feedback 3. Workflow Analysis Evaluation Phase of Pilot Data: 2D and linear barcoded vaccination data Data Sources: IIS records, EMR records, Shipping manifests, Vaccine inventory logs, Manufacturer product logs Analysis: Descriptive and inferential statistics, Confidence intervals, T-te sts, Linear regression 17

Workflow Analysis Purpose: To help understand the impact of 2D scanners and barcoded products on vaccine administration and inventory processes Pre-2D St ate Mar 2012 May 2012 No 2D barcoded technology Limited or scanning procedures 2D barcoded vaccines not available Post -2D St ate Jan 2013 Mar 2013 2D barcoded technology in place 2D scanning procedures matured 2D barcoded vaccines in supply Approach: Process maps, time measurements and staff interviews collected before and after the introduction of 2D capabilities provide the basis to measure the effected change. 18

Workflow Analysis Example Summary Findings Standards: Inventory and vaccination procedures have minimal variance regardless of practice size or type Opportunities: Similar EMR functional enhancement requests were observed in most practices. Challenges: Adoption may lag - reluctance to change established procedures Perceptions: Interviews - candid practitioner expectations and thoughts Really it is the best thing that has happened for the practice with respect to vaccines. We have been asking for it for 8 years. This new process will be more about accuracy; not so much a time saver. For high volume practices the time savings will be great. It adds up to a small lunch break every week. As I am getting older they make the numbers smaller 19

Identified barcode VIS 2D Barcoding Selected GS1 s Global Document Type Identifier (GDTI) to encod e VIS document type Added VIS edition date to GS1 DataMatrix Developed frequently asked questions for users CDC VIS Barcode Web-page Rolling out barcodes on new VIS 20

2dbarcodepilot.com http://www.2dbarcodepilot.com 21

Thank You-Happy Scanning For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. 22 National Center for Immunization and Respiratory Diseases Immunization Services Division